CLASS II Drug recall · Reported 24 Jan 2018 · FDA Enforcement Report
Lovastatin Tablets USP, 40 mg Unit Dose recalled by AVKARE
Avkare is recalling Lovastatin Tablets USP, 40 mg Unit Dose, distributed nationwide in the US. The recall was initiated on 3 Jan 2018 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0222-2018
- FDA event ID
- 78867
- Recalling firm
- Avkare, Pulaski, TN
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 3 Jan 2018
- FDA classified
- 12 Jan 2018
- Reported
- 24 Jan 2018
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
- Drug class
- Cholesterol Medication
Timeline
| 3 Jan 2018 | Recall initiated by company | |
| 12 Jan 2018 | Classified by FDA | +9 days |
| 24 Jan 2018 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Failed Dissolution Specifications: Low out of specification results for dissolution during annual stability testing.
Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.
Product as listed by the FDA
Lovastatin Tablets USP, 40 mg, 50 Tablets (5x10) Unit Dose carton, Rx only, Manufactured for AvKARE, Inc. Pulaski, TN 38478, NDC 50268-512-15.
Where it was distributed
Nationwide in the USA
Questions about this recall
Why was it recalled?
Failed Dissolution Specifications: Low out of specification results for dissolution during annual stability testing.
Which lots are affected?
Lot: 15270, Exp. 01/18
Where was it sold?
Nationwide in the USA
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Avkare
All 62| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Amantadine HCl, Capsules, UPS, 100 mg dose recalled by AvKAREAmantadine Hcl | AvKARE | Potency & Assay | Nationwide |
| Drug | CLASS II | Rosuvastatin Tablets, USP, 10 mg recalled by AvKARERosuvastatin | AvKARE | Potency & Assay | Nationwide |
| Drug | CLASS II | Norgestimate and Ethinyl Estradiol Tablets recalled by AvKARENorgestimate And Ethinyl Estradiol | AvKARE | Other | Nationwide |
| Drug | CLASS II | chloroproMAZINE Hydrochloride Tablets, USP, 100 mg unit dose recalledChlorpromazine Hydrochloride | AvKARE | Other | Nationwide |
| Drug | CLASS II | chloroproMAZINE Hydrochloride Tablets, USP, 50 mg unit dose recalledChlorpromazine Hydrochloride | AvKARE | Other | Nationwide |
Other Lovastatin recalls
All 4| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS III | Lovastatin Tablets USP, 40 mg recalled by American Health PackagingLovastatin | American Health Packaging | Potency & Assay | Nationwide |
| Drug | CLASS III | Lovastatin Tablets USP, 40 mg recalled by Lupin PharmaceuticalsLovastatin | Lupin Pharmaceuticals | Potency & Assay | Nationwide |
| Drug | CLASS II | Lovastatin, Tablet, 20 mg recalled by Aidapak Services | Aidapak Services | Labeling Errors | 4 states |